No compensation for faulty medical devices

When Charles Riegel underwent surgery after a heart attack in 1996, no one could have guessed that his operation would lead to a Supreme Court decision that could affect the safety of patients across the US.

During surgery, an inflatable catheter designed to open Riegel’s coronary artery ruptured, leaving him severely injured. Riegel and his wife sued Medtronic, the manufacturer of the device, but defence lawyers argued that the firm could not be held responsible as the catheter had been approved by the Food and Drug Administration. Last week, the Supreme Court agreed, saying that this ruled out legal action.

This worries public health experts because recent reports from the Government Accountability Office, the Institute of Medicine and some of the FDA’s own advisers have concluded that the FDA lacks the staff and funding to properly oversee patient safety. When the FDA fails, say experts, legal action is needed to protect patients. Some members of Congress have vowed to reverse the court decision, but the problem could get worse first as the ruling may be extended later this year to include cases involving drug manufacturers.

To continue reading this premium article, subscribe for unlimited access.